Clinical Trials Information System (CTIS): Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023

• Date:
  Friday, 20 January 2023, 10:00 - 13:00 Amsterdam time (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

The Clinical Trials Information System (CTIS) was launched on 31 January 2022, starting the clock for one-year transition period for all sponsors of clinical trials.

During the transition period, clinical trial sponsors can choose whether to submit an initial clinical trial application in line with the Clinical Trials Directive or under the Clinical Trials Regulation (CTR), via CTIS.

Starting from 31 January 2023, the use of CTIS will be mandatory for all initial clinical trial application in the European Union (EU).

The European Medicines Agency is offering this open event to provide:

• reflection on the implementation of the Clinical Trials Regulation;
• update on the current status of CTIS;
• outlook on 2023/2024 CTIS planning.

EMA cannot provide attendees certificates of attendance for this event.

A video recording is made available after the event. Processing and publication of the video recording typically take up to 60 days. Please subscribe to the Clinical Trials Highlights newsletter for updates on the availability of CTIS event video recordings.

Documents

Agenda - Clinical Trials Information System (CTIS): Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023

CTIS - Readiness for Mandatory use of the CTR from 31 January 2023 - Presentation deck

Speaker Bios

Reference Number: EMA/33990/2023

Video recording

Live participation via Slido

• Participants can ask questions in advance, from 9 - 16 January 2023, via the audience interaction tool Slido. Please go to www.sli.do and enter the event code “#CTIS2023”.
• Interaction via Slido is voluntary, and you may opt to remain anonymous. If you choose to use Slido, you consent to process your personal data as explained in the .